FDA Grants HemoSonics 510(k) Clearance to Expand Use of Its Quantra Hemostasis System to Obstetric Procedures

The Quantra Hemostasis System provides comprehensive blood analysis that delivers rapid, real-time coagulation insights at the point of need, empowering clinicians with actionable data to make better decisions and protect mothers who experience postpartum hemorrhage during childbirth. Quantra is the first and only cartridge-based FDA-cleared viscoelastic testing platform for obstetrics.

DURHAM, N.C.--(BUSINESS WIRE)--HemoSonics LLC, a medical device company focused on acute bleeding management, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded use of its Quantra® Hemostasis System with QStat® Cartridge in peripartum obstetric procedures. The Quantra Hemostasis System delivers rapid, real-time coagulation insights at the point of need, empowering clinicians with actionable data to make confident decisions and protect women at risk of experiencing postpartum hemorrhage during childbirth. Quantra is the first and only cartridge-based, FDA-cleared viscoelastic testing (VET) platform for obstetric bleeding.

Severe bleeding after childbirth is the leading cause of maternal mortality globally, according to the World Health Organization. Roughly 14 million women worldwide experience postpartum hemorrhage (PPH) annually, resulting in approximately 70,000 deaths. The problem does not just affect developing nations. The United States reports 21.1 deaths per 100,000 live births, almost twice the Organization for Economic Cooperation and Development average, with more than 10% of maternal deaths due to bleeding.

“The expansion of the Quantra Hemostasis System to the obstetric population will empower clinicians with crucial, real-time, actionable data to help care teams quickly assess and manage severe bleeding in women at risk for postpartum hemorrhage after childbirth,” said HemoSonics’ President and CEO Bob Roda. “HemoSonics is setting a new standard for ease of use, speed and accuracy at the point of need. We’re committed to fighting the maternal mortality crisis worldwide by advancing technology that helps women have safe and healthy deliveries.”

HemoSonics pioneered the first cartridge-based viscoelastic testing system—the Quantra Hemostasis System—which includes the Quantra Hemostasis Analyzer with QPlus and QStat Cartridges. The Quantra System uses innovative SEER Sonorheometry (sonic estimation of elasticity via resonance), a proprietary medical-grade ultrasound technology that measures the coagulation properties of a whole blood sample. The diagnostic insights produced by Quantra enable healthcare clinicians to make individualized and evidence-based decisions regarding the management of bleeding patients, optimize blood product use, and improve patient outcomes. The Quantra System requires minimal resources to maintain, is easy to operate and interpret, and provides fast, comprehensive whole-blood coagulation analysis at the point of need, typically in less than 15 minutes.

“The Quantra System has the broadest range of FDA-cleared clinical indications, including cardiovascular and major orthopedic surgery, trauma and liver transplantation in point-of-care and laboratory settings,” added Roda. “Now the same life-saving insight is available for obstetrics. Beyond technology, HemoSonics provides comprehensive clinical and operational support services that help hospitals implement and expand viscoelastic testing programs with confidence.”

HemoSonics received the grand prize in the 2024 National Institutes of Health (NIH) RADx Tech for Maternal Health Challenge, which seeks to accelerate the development of innovative diagnostic tools and solutions that address maternal mortality. A recent retrospective cohort study published in the International Journal of Obstetric Anesthesia demonstrated that Quantra QStat Cartridge parameters enabled the rapid and reliable detection of blood-clotting disorders during postpartum hemorrhage in 130 patients.

Email [e-mail] to learn more about HemoSonics’ Quantra Hemostasis System or visit https://hemosonics.com.

About HemoSonics

HemoSonics, LLC is a medical device technology company focused on acute bleeding management, resulting in better patient care and lower overall medical costs. The Quantra Hemostasis Analyzer, HemoSonics' flagship product, is designed to improve patient outcomes and reduce healthcare costs by providing optimized coagulation information. The Quantra System's easy and fast interpretation enables simple, more efficient point-of-care and laboratory bleeding management.

Based in Durham, NC, HemoSonics is part of the Stago Group, a leading in vitro diagnostics company dedicated to exploring thrombosis and hemostasis. Follow HemoSonics on LinkedIn or visit HemoSonics.com to learn more.